A Study Of Blood Based Biomarkers For Pancreas Adenocarcinoma

Study Overview

A Study of Blood Based Biomarkers for Pancreas Adenocarcinoma

The purpose of this study is to develop a minimally invasive test to diagnose pancreatic cancer at early stages of disease and monitor response to treatment.

N/A

Pancreatic Cancer
Pancreatic Diseases
Pancreatitis
Pancreatic Cyst

DIAGNOSTIC_TEST: Blood Draw
DIAGNOSTIC_TEST: Tumor Tissue Collection
DIAGNOSTIC_TEST: Cyst Fluid

17-527

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2025-07-22
First Submitted that Met QC Criteria 2017-11-02	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2025-07-23
First Posted (ACTUAL) 2017-11-07	Results First Posted N/A	Last Verified 2025-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Locally Advanced or Metastatic Pancreatic Cancer Cohort For patients with locally advanced or metastatic PDAC, blood will be collected pre-treatment initiation (baseline), after first chemotherapy cycle, every 8-12 weeks while under treatment to coincide with restaging CT scan and at time of disease progressio	DIAGNOSTIC_TEST: Blood Draw If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL DIAGNOSTIC_TEST: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
: Acute Benign Pancreatic Pathology Control Cohort For patients with acute pancreatitis, blood specimens will be drawn at the time of acute pancreatitis and every 6-12 months thereafter	DIAGNOSTIC_TEST: Blood Draw If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL DIAGNOSTIC_TEST: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
: Chronic Benign Pancreatic Path,IPMC & Pancreatic Cyst Ctrl For patients with chronic pancreatitis, IPMN, or cysts, blood specimens will be drawn every 6-12 months.	DIAGNOSTIC_TEST: Blood Draw If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL DIAGNOSTIC_TEST: Tumor Tissue Collection Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere DIAGNOSTIC_TEST: Cyst Fluid Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
: Healthy Control For normal controls, blood specimens will be drawn once at study baseline.	DIAGNOSTIC_TEST: Blood Draw If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria: Patients and controls weighing 50kg or more * For draw amounts up to 50mL, there is no required hemoglobin threshold. * For amounts exceeding 50mL

Primary Outcome Measures	Measure Description	Time Frame
Change in biomarkers to determine sensitivity and specificity of the assay to diagnose early stage pancreatic cancer		4 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Kenneth Yu, MD

Phone Number: 646-888-4188

Email: yuk1@mskcc.org

Study Contact Backup

Name: David Kelson, MD

Phone Number: 646-888-4179

Email:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:
1

Radiological, histological or cytological confirmed diagnosis of locally advanced or metastatic pancreatic adenocarcinoma by the enrolling institution
Patient planning to receive systemic treatment
Hemoglobin > 8
ECOG performance status 0-2
A minimum age of 18 years old
Willing to undergo a tumor biopsy
Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Radiological, histological or cytological confirmed diagnosis of pancreatic adenocarcinoma by the enrolling institution
Patient planned to undergo upfront resection
No pre-operative systemic therapy nor chemoradiation therapy planned
Hemoglobin > 8
ECOG performance status 0-2
A minimum age of 18 years old
Willing to undergo a tumor biopsy
Willing to provide permission to obtain banked tumor tissue for analysis (previous biopsies or surgical material).

Confirmed diagnosis of acute pancreatitis or other acute pancreatic pathology by the enrolling institution
Hemoglobin > 8
ECOG performance status 0-2
A minimum age of 18 years old

Confirmed diagnosis of chronic pancreatitis or other non-cystic chronic pancreatic pathology by the enrolling institution
Hemoglobin > 8
ECOG performance status 0-2
A minimum age of 18 years old

Confirmed diagnosis of IPMN without high risk features by the enrolling institution
A minimum age of 18 years old

Confirmed diagnosis of benign pancreatic cyst by the enrolling institution
A minimum age of 18 years old

A minimum age of 18 years old

Prior chemotherapy or radiation therapy for pancreatic cancer within the last 3 months in the localized setting
Active second malignancy, unless low grade malignancy
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Neoadjuvant chemotherapy or radiation therapy is planned
Active second malignancy, unless low grade malignancy
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Active or prior malignancy, except prior non-melanoma skin cancer
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Active or prior malignancy, except prior non-melanoma skin cancer
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

IPMN with high risk features or planned resection
Active or prior malignancy, except prior non-melanoma skin cancer
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Active or prior malignancy, except prior non-melanoma skin cancer
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Active or prior malignancy, except prior non-melanoma skin cancer
Proven to be a carrier of a cancer susceptibility gene or family history concerning for genetic predisposition to cancer
Any medical or psychiatric condition that may interfere with ability to comply with protocol procedures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sheba Medical Center
Weill Medical College of Cornell University
Weizmann Institute of Science

Investigators

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record